Pulmonary Disease, Chronic ObstructiveCOPDwearNCT03857061
A Wearable and a Self-management Application for Chronic Obstructive Pulmonary Disease (COPD) Patients at Home
An observational study of Pulmonary Disease, Chronic Obstructive, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with Chronic Obstructive Pulmonary Disease (COPD), which provides them with appropriate self-management tools and detects AECOPDs early to permit prompt treatment and prevent severe exacerbations… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- smartphone, smartwatch, WearCOPDv2 application
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jun 2019to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will recruit patients who have clinically relevant COPD who live at home. They will be identified in clinics and the wards by members of their care team. Posters informing people of the study will also be posted at University Health Network (UHN) with a contact number.
Who may be able to join
- Able to speak English
- Moderate to very severe COPD (GOLD C and D) as defined by the GOLD guidelines
- Clinically relevant disease, as defined by a history of exacerbation in the previous 12 months
- Previous spirometry or Pulmonary Function Test results of Forced Expiration Volume/Forced Vital Capacity (FEV1/FVC) <0.70 with an FEV1 below 80% predicted
- Patient resides at home (not long term care residence or another hospital)
Who cannot join
- Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma
- Rapid lethal disease, e.g. lung cancer, advance heart failure, end-stage renal disease
- Any medical conditions that would impair their ability to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COPDwear V2 - A Wearable and a Self-management Application for COPD Patients at Home: a Pilot Prospective Cohort Study
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with Chronic Obstructive Pulmonary Disease (COPD), which provides them with appropriate self-management tools and detects AECOPDs early to permit prompt treatment and prevent severe exacerbations requiring hospitalization.
Read the detailed description
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with COPD, which provides them with appropriate self-management tools and detects Acute Exacerbations of COPD (AECOPDs) early to permit prompt treatment and prevent severe exacerbations requiring hospitalization. Currently, the investigators are developing a second version of this app, WearCOPDv2. This app will incorporate features identified as being desirable from our patient interviews: 1) new sensor that was requested by patients - oxygen saturation, and 2) the app will incorporate a patient-facing interface as patients requested a method to view their data as well as access to information to learn how to manage their condition better.
Research questions:
Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?
What is the accuracy of our sensor data (heart rate, activity, respiratory rate, oxygen saturation, coughing, and other sounds of interest) in detecting early AECOPDs?
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- smartphone, smartwatch, WearCOPDv2 application
- Keywords
- wearables, self-monitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone, smartwatch, WearCOPDv2 applicationDevice
WearCOPD2 consists of hardware and software components.
6.1 Hardware The hardware for wearCOPDv2 consists of three main components; (1) a smartwatch, (2) a phone, and (3) a server.
6.2 Software
The wearCOPDv2 system has two main software components:
- Data collection service
- Participant user interface
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients | This is a prospective cohort study enrolling patients with COPD to 1) wear a smartwatch that passively senses heart rate, motion, audio, 2) use a smartphone that can obtain oxygen saturation upon demand, 3) use a self-management app on the smartwatch, smartphone and a webapp. Receives: Device: smartphone, smartwatch, WearCOPDv2 application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire
Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?
We will use the Mastery sub-section of the Chronic Respiratory Disease Questionnaire to measure our research question. Mastery is measured with a 7-point likert scale where higher scores indicate better health-related mastery.
Measured: 6 months
Secondary outcomes (4)
Change in self-efficacy as measured by the COPD Self-Efficacy Scale
Can an app designed for patients with COPD that includes biosensor feedback improve self-efficacy of COPD?
This will be measured by the COPD self-efficacy scale. Participants will determine how confident they are that they could manage breathing difficulty or avoid breathing difficulty in certain situations. Usin the following scale.
- Very confident
- Pretty confident
- Somewhat confident
- Not very confident
- Not at all confident
A lower score indicates higher self-efficacy.
Measured: 6 months
Change in Health related quality of life as measured by the St. George's respiratory questionnaire
Can an app designed for patients with COPD that includes biosensor feedback improve health related quality of life?
Scoring and Scales
Questions 1 - 7 Scale: Most days a week - Not At All
Where a patient has ticked a box, a value of 1 is entered for the appropriate question.
Question 8 Where a patient has ticked 'Yes' to having a worse wheeze in the morning, a value of 1 is entered for the appropriate question.
Questions 9, 10 \& 17 Where a patient has ticked a box, a value of 1 is entered for the appropriate question.
Questions 11 - 16 Where a patient has ticked 'True' a value of 1 is entered for the appropriate question.
In response to question 14, if a patient is not receiving medication, enter the responses as zero.
Score = 100 x (Summed weights from positive items in the questionnaire divided by the Sum of weights for all items in the questionnaire)
lower scores indicate higher health related quality of life
Measured: 6 months
Change in symptom scale as measured by the MRC dyspnea scale
Can an app designed for patients with COPD that includes biosensor feedback improve COPD symptoms?
The MRC Dyspnea scale asks you to rate your breathlessness on a 5 point likert scale.
Measured: 6 months
Accuracy of our derived prediction algorithm to detect acute exacerbations as measured by the daily symptom score.
We will correlate sensor data from the smartwatch to exacerbations defined by the daily symptom score.
The daily symptom score asks about daily symptoms of COPD and patients are asked to answer yes or no to whether or not they have experienced a decline of any of the symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start29 Jun 2019
- Primary completion1 Jun 2021
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Samsung Electronics
- Responsible party
- Principal investigator, Robert Wu, University Health Network, Toronto
- Investigators
- Robert Wu, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857061
- Sponsor's protocol ID
- 18-5462
- Acronym
- COPDwear
- Status last verified
- Jan 2025
- First submitted
- 23 Jul 2018
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: UHN, research personnel will have direct access to the source documents with identifying information. UHN, University of Toronto (UofT) and Samsung Research America (SRA) will have access to the anonymized subject data for analysis purposes.
Publications
Wu R, de Lara E, Liaqat D, Liaqat S, Chen JL, Son T, Gershon AS. Feasibility of a wearable self-management application for patients with COPD at home: a pilot study. BMC Med Inform Decis Mak. 2024 Mar 5;24(1):66. doi: 10.1186/s12911-024-02461-y.
PubMed 38443858
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPDwear V2 - A Wearable and a Self-management Application for COPD Patients at Home: a Pilot Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03857061
- Acronym / sponsor ID
- COPDwear / 18-5462
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- wearables, self-monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Toronto, Samsung Electronics
- Study start
- 29 Jun 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with Chronic Obstructive Pulmonary Disease (COPD), which provides them with appropriate self-management tools and detects AECOPDs early to permit prompt treatment and prevent severe exacerbations requiring hospitalization.
Detailed description
Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with COPD, which provides them with appropriate self-management tools and detects Acute Exacerbations of COPD (AECOPDs) early to permit prompt treatment and prevent severe exacerbations requiring hospitalization. Currently, the investigators are developing a second version of this app, WearCOPDv2. This app will incorporate features identified as being desirable from our patient interviews: 1) new sensor that was requested by patients - oxygen saturation, and 2) the app will incorporate a patient-facing interface as patients requested a method to view their data as well as access to information to learn how to manage their condition better.
Research questions:
Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?
What is the accuracy of our sensor data (heart rate, activity, respiratory rate, oxygen saturation, coughing, and other sounds of interest) in detecting early AECOPDs?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Patients | – | Device: smartphone, smartwatch, WearCOPDv2 applicationThis is a prospective cohort study enrolling patients with COPD to 1) wear a smartwatch that passively senses heart rate, motion, audio, 2) use a smartphone that can obtain oxygen saturation upon demand, 3) use a self-management app on the smartwatch, smartphone and a webapp. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit patients who have clinically relevant COPD who live at home. They will be identified in clinics and the wards by members of their care team. Posters informing people of the study will also be posted at University Health Network (UHN) with a contact number.
Key inclusion criteria (5 listed)
- Able to speak English
- Moderate to very severe COPD (GOLD C and D) as defined by the GOLD guidelines
- Clinically relevant disease, as defined by a history of exacerbation in the previous 12 months
- Previous spirometry or Pulmonary Function Test results of Forced Expiration Volume/Forced Vital Capacity (FEV1/FVC) <0.70 with an FEV1 below 80% predicted
- Patient resides at home (not long term care residence or another hospital)
Key exclusion criteria (3 listed)
- Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma
- Rapid lethal disease, e.g. lung cancer, advance heart failure, end-stage renal disease
- Any medical conditions that would impair their ability to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smartphone, smartwatch, WearCOPDv2 applicationWearCOPD2 consists of hardware and software components. 6.1 Hardware The hardware for wearCOPDv2 consists of three main components; (1) a smartwatch, (2) a phone, and (3) a server. 6.2 Software The wearCOPDv2 system has two main software components: 1. Data collection service 2. Participant user interface | Device | COPD Patients |
Primary outcome
Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire
Time frame: 6 months
Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD? We will use the Mastery sub-section of the Chronic Respiratory Disease Questionnaire to measure our research question. Mastery is measured with a 7-point likert scale where higher scores indicate better health-related mastery.
4 secondary outcomes
Change in self-efficacy as measured by the COPD Self-Efficacy Scale
Time frame: 6 months
Change in Health related quality of life as measured by the St. George's respiratory questionnaire
Time frame: 6 months
Change in symptom scale as measured by the MRC dyspnea scale
Time frame: 6 months
Accuracy of our derived prediction algorithm to detect acute exacerbations as measured by the daily symptom score.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 38443858Wu R, de Lara E, Liaqat D, Liaqat S, Chen JL, Son T, Gershon AS. Feasibility of a wearable self-management application for patients with COPD at home: a pilot study. BMC Med Inform Decis Mak. 2024 Mar 5;24(1):66. doi: 10.1186/s12911-024-02461-y.
- Individual participant dataSharing planned: Yes. UHN, research personnel will have direct access to the source documents with identifying information. UHN, University of Toronto (UofT) and Samsung Research America (SRA) will have access to the anonymized subject data for analysis purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wu principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-management as measured by the Mastery sub-section of the Chronic Respiratory Disease Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.